By Mitchell Young
NEW HAVEN: Alexion [Nasdaq: ALXN] stock is battling off another a report of an investigation. The company has reported that it is under investigation by the U.S. Department of Health and Human Services’ Office of Inspector General. The HSS is looking at allegations relating to Alexion’s support of, for charities that support Medicare patients by the U.S. Attorney’s Office in Massachusetts.
“We are aware that the U.S. Department of Health and Human Services Office of Inspector General is working on this inquiry with the U.S. Attorneys’ Office and the Department of Justice,” Alexion said July 6 th in a statement.
Alexion had previously reported in January that it had been subpoenaed by the U.S. Attorney requesting documents about the company’s support for charities that give financial assistance to Medicare patients, Alexion has said it is cooperating with the investigation and that other companies were also included in the probe.
Washington> Stamford-based Purdue Pharma, the maker of pain-killer OxyContin, is the target of an increasing number of states, counties and cities suing the pharmaceutical firm, alleging it is partly to blame for the nation’s opioid epidemic.
The lawsuits are all different and some include other pharmaceutical companies and pharmacies as defendants. But Purdue is nearly always a main defendant.
The latest suit, filed last week by the state of Oklahoma, said Purdue and three other drug companies and their subsidiaries sought to increase their opioid sales by persuading doctors to expand the market beyond “a niche for cancer patients, the terminally ill and acute short-term pain” and to “prescribe opioids to a broader range of patients with chronic non-cancer-related pain.”
New Haven: Three executives from pharma giant Bristol Myers Squibb [NYSE: BMY] are finding new homes at two affiliated New Haven biotech companies. Biohaven [NYSE: BHVN] which went public two months ago with a $168 million IPO has hired two former BMY execs for key leadership positions as the company continues to move forward on developing its diverse portfolio of drugs.
|Manion: new CEO at KLEO|
|Stock: appointed head of Portfolio Strategy and Development at Biohaven|
|McGrath: Chief of Corporate Strategy and Business Development, Biohaven.|
Elyse Stock, M.D. has been appointed as the company's Chief of Portfolio Strategy and Development, and St. John (Donnie) McGrath, M.D. has been appointed as Chief of Corporate Strategy and Business Development.
Douglas Manion, M.D., FRCP(C), as the new CEO of Kleo Pharmaceuticals. Manion has most recently served as SVP head of specialty development at BMS. Kleo's lead investor is Biohaven.
David Spiegel, M.D., Ph.D. co-founder of Kleo who’s technology is based on the work of his lab at Yale University, was himself appointed CEO this past September soon after the investment led by Biohaven.
Stock was most Vice-President Global Development Leader at Bristol-Myers Squibb (BMS), where she worked for the last 19 years in various positions “developing numerous investigational agents across multiple therapeutic areas including neuroscience, oncology, immunology and cardiovascular disease.”
McGrath, served as Vice President of Business Development and Head of Search & Evaluation. was responsible for overseeing BMS' venture capital investment portfolio and provided leadership for all global external partnering activities.
Old Saybrook: Iterum Therapeutics US Limited, of Dublin Ireland is expanding its space and commitment in Old Saybrook. The company has leased 9413 square feet, at 20 Research Parkway. The company currently occupies only 2300 square feet in building, the US director is Corey Fishman.
Iterum is a clinical stage biotech business with offices in Chicago, Dublin, Ireland, and Old Saybrook, they recently raised $65 million in a Series B Financing to support a phase 3 clinical trial for a new anti-biotic to treat urinary tract infections.
The financing was led by new investor Arix Bioscience plc, and included Pivotal bioVenture Partners, Advent Life Sciences, Domain Associates and Bay City Capital. Acording to the company alll of its current investors (Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures and New Leaf Venture Partners) also participated in the round.
The owner of the complex is Mill Meadow Development, LLC. Kevin Geenty SIOR was the sole agent in this transaction.
By Mitchell Young
Shares of Alexion stock have taken off after being pummeled by concerns about executive turnover at the company and reports of “aggressive sales practices." The C-Suite changes were initiated by new CEO Ludwig Hantson.
The stock was trading at $96.95 as recently as May 26, down from a 52 week high of $145.
On June 14, after the announcement, filling the last of the company’s major management slots, with the hiring of Paul Clancy the day before, as the new CFO. [Clancy was previously with Biogen of Cambridge, MA, see New CFO and A Possible Looming Write Off - Help Boost Alexion Stock ] the stock made a 9% plus gain.
On June 14, Hantson purchased $1.16 million of the stock in the open market at approximately $116 per share. He was joined by Alexion board members Christopher Couglin who picked up $230,000 of shares and Alvin Parven who purchased $100,000 worth, both at around $116 per share as well.
By Mitchell Young
New Haven: The FDA has approved Melinta Therapeutics' Baxdela (delafloxacin), a fluoroquinolone antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The company was founded by three of Yale University's leading scientist-researchers in 2000 as RIBx. The company first began work on the drug when it licensed it in 2006 under the then CEO Susan Froshauer, now CEO of Connecticut United for Resource Excellence [CURE].
The FDA also provided Qualified Infectious Disease Product (QIDP)Status which provides for an additional five-year period of market exclusivity for the approved purpose.
|New CFO Paul Clancy brought a rise in the company's stock price with him.|
By Mitchell Young
New Haven: Continued reports in the New Haven Register questioning the ethics and viability of Alexion have failed to halt a major rebound in the company’s stock. Alexion’s stock has increased by more than 22% percent [20 points] since Register reporting and short sellers questioned the company’s viability.
On June 13, Alexion named long-time Cambridge based Biogen Inc [Nasdaq: BIIB] CFO Paul Clancy, Chief Financial Officer of Alexion.
Biogen does nearly four times the revenue of Alexion and has double the market value. Wall Street analysts were very positive about the choice, and his hiring was apparently seen as evidence that there would not be “another shoe to drop” in terms of revelations about changes at the company.
Alexion stock had tanked amid media reports about the company’s “aggressive” marketing practices and a turn-over of executives that has followed the appointment of New CEO Ludwig Hantson. Hantson has replaced the core of Alexion’s management team, appointing four executives from his previous company, Baxalata [see Alexion CEO: Putting The New, Old Band Back Together].
Likewise, Clancy comes to Alexion after Biogen’s new CEO Michel Vounatsos has turned over his management team, amid complaints of lackluster performance. Clancy’s appointment created a 9% boost in Alexion’s stock.
Also on June 13, investment news site www.seekingalpha.com reported that Hantson floated the idea at the Golldman Sachs Healthcare Conference, that he is considering writing off the investment of one of the company's key drugs, Kanuma. The report said “he referred to the commercial results as near the bottom on biotech launches.
Kanuma is an enzyme replacement therapy for an ultra-rare inherited metabolic disorder, it was approved by the FDA at the end of 2015.
Sales of the drug were under $26 million for the full 2016 year. Alexion paid $8.4 billion in June of 2015 for Cambridge based Synageva BioPharma Corp. [Nasdaq:GEVA].
Alexion founder Leonard Bell and the CEO that initiated the acquisition justified the price at the time, saying the drug would eventually bring “$1 billion in sales.”
At the time of the closing of the acquisition, then Alexion’s CEO David Hallal, said, “as we complete this acquisition, the combination of our two companies provides us the exciting opportunity to build upon our collective strengths and talents to firmly establish Alexion as the global leader in serving patients with devastating and rare diseases, With Soliris, [Alexion’s flagship now $3 billion sales drug] and the anticipated approvals of Strensiq and Kanuma, Alexion is poised to have three innovative products serving patients with four severe diseases in 2015 while also advancing the deepest and broadest pipeline in our history.”
Stensiq was acquired in 2011 with the acquisition of Montreal based Enobia Pharma for under $1 billion and was also approved in 2015. Sales for this year  are expected to exceed $200 million. Previous estimates for the two drugs were $1.5 -$2 billion annually.